Late last year, French legislators quietly slipped a measure into the country's 2014 budget legislation that would allow pharmacists to substitute inexpensive biosimilar drugs for pricier biotech brands. While not a full-out assault on branded biologics, it would make France the first European country to substitute the cheaper drugs, and the pharma industry is doing everything it can to derail that move before France's Administrative Supreme Court decrees it into effect.
Executives representing drugmakers such as France's Sanofi ($SNY) as well as Roche ($RHHBY) and Amgen ($AMGN) are angry they weren't consulted about the law and are now meeting with government officials, pharmacists and doctors in France to discuss the decree, according to Reuters. A working group from France's health administration is on track to make recommendations in June, after which the decree would be handed down within a few months.
Biosimilars could save France between €500 million and €1 billion ($690 million and $1.4 billion) by 2020, estimates Claude Le Pen, an economist at Paris-Dauphine University, according to Reuters. The law would limit that savings, however, because it would apply only to patients who are starting a new course of treatment and who are getting their drugs from retail pharmacies, rather than hospitals. Furthermore, doctors would be allowed to demand patients get the original branded biotech products.
Still, some pharma companies are worried the biosimilar-substitution law--not to mention its surreptitious debut--will make France an unattractive investment target. "We often complain that France and its regulations are incomprehensible and unpredictable, but what happened with biosimilars is a caricature of that," Philippe Lamoureux, head of the French pharmaceutical trade association Leem, told Reuters.
France may be the first European country to move aggressively on biosimilars, but it won't be the last. A raft of biotech blockbusters are racing toward patent expiration, prompting generics manufacturers to line up with cheaper alternatives. Last week, Hospira ($HSP) persuaded a U.K. court to overturn two patents on Roche's breast cancer drug Herceptin, opening up the possibility for biosimilar competition there. Hospira and its South Korean partner Celltrion last year got European approval for Inflectra, a biosimilar of Johnson & Johnson's ($JNJ) rheumatoid arthritis drug Remicade, Europe's first biosimilar of a monoclonal antibody (mAb) therapy. Indian drugmaker Lupin has 10 biosimilars in development. And earlier this year, the U.K.-based contract researcher BioOutsource said it was bulking up to meet demand in the global biosimilar market, which it estimates will double to $19 billion by 2018.